Ventricular partitioning device

ABSTRACT

This invention is directed to a partitioning device for separating a patient&#39;s heart chamber into a productive portion and a non-productive portion. The device is particularly suitable for treating patients with congestive heart failure. The partitioning device has a frame-reinforced, expandable membrane which separates the productive and non-productive portions of the heart chamber. The proximal ends of the ribs of the frame have tissue penetrating elements about the periphery thereof which are configured to penetrate tissue lining the heart wall at an angle approximately perpendicular to a longitudinal axis of the partitioning device. The partitioning device has a hub with a non-traumatic distal end to engage the ventricular wall.

FIELD OF THE INVENTION

The present invention relates generally to the field of treatingcongestive heart failure and more specifically, to a device and methodfor partitioning a patient's heart chamber and a system for deliveringthe treatment device.

BACKGROUND OF THE INVENTION

Congestive heart failure (CHF) is characterized by a progressiveenlargement of the heart, particularly the left ventricle and is a majorcause of death and disability in the United States. Approximately500,000 cases occur annually in the U.S. alone. As the patient's heartenlarges, it cannot efficiently pump blood forward with each heart beat.In time, the heart becomes so enlarged the heart cannot adequatelysupply blood to the body. Even in healthy hearts only a certainpercentage of the blood in a patient's left ventricle is pumped out orejected from the chamber during each stroke of the heart. The pumpedpercentage, commonly referred to as the “ejection fraction”, istypically about sixty percent for a healthy heart. A patient withcongestive heart failure can have an ejection fraction of less than 40%and sometimes lower. As a result of the low ejection fraction, a patientwith congestive heart failure is fatigued, unable to perform even simpletasks requiring exertion and experiences pain and discomfort. Further,as the heart enlarges, the internal heart valves such as the mitralvalve, cannot adequately close. An incompetent mitral valve allowsregurgitation of blood from the left ventricle back into the leftatrium, further reducing the heart's ability to pump blood forewardly.

Congestive heart failure can result from a variety of conditions,including viral infections, incompetent heart valves (e.g. mitralvalve), ischemic conditions in the heart wall or a combination of theseconditions. Prolonged ischemia and occlusion of coronary arteries canresult in myocardial tissue in the ventricular wall dying and becomingscar tissue. Once the myocardial tissue dies, it is less contractile(sometimes non-contractile) and no longer contributes to the pumpingaction of the heart. It is referred to as hypokinetic. As the diseaseprogresses, a local area of compromised myocardium may bulge out duringthe heart contractions, further decreasing the heart's ability to pumpblood and further reducing the ejection fraction. In this instance, theheart wall is referred to as dyskinetic or akinetic. The dyskineticregion of the heart wall may stretch and eventually form an aneurysmicbulge.

Patients suffering from congestive heart failure are commonly groupedinto four classes, Classes I, II, III and IV. In the early stages,Classes I and II, drug therapy is presently the most commonly prescribedtreatment. Drug therapy typically treats the symptoms of the disease andmay slow the progression of the disease, but it can not cure thedisease. Presently, the only permanent treatment for congestive heartdisease is heart transplantation, but heart transplant procedures arevery risky, extremely invasive and expensive and are performed on asmall percentage of patients. Many patient's do not qualify for hearttransplant for failure to meet any one of a number of qualifyingcriteria, and, furthermore, there are not enough hearts available fortransplant to meet the needs of CHF patients who do qualify.

Substantial effort has been made to find alternative treatments forcongestive heart disease. For example, surgical procedures have beendeveloped to dissect and remove weakened portions of the ventricularwall in order to reduce heart volume. This procedure is highly invasive,risky and expensive and is commonly only done in conjunction with otherprocedures (such as heart valve replacement or coronary artery by-passgraft). Additionally, the surgical treatment is usually limited to ClassIV patients and, accordingly, is not an option for patients facingineffective drug treatment prior to Class IV. Finally, if the procedurefails, emergency heart transplant is the only presently availableoption.

Other efforts to treat CHF include the use of an elastic support, suchas an artificial elastic sock placed around the heart to prevent furtherdeleterious remodeling.

Additionally, mechanical assist devices have been developed asintermediate procedures for treating congestive heart disease. Suchdevices include left ventricular assist devices and total artificialhearts. A left ventricular assist device includes a mechanical pump forincreasing blood flow from the left ventricle into the aorta. Totalartificial heart devices, such as the Jarvik heart, are usually usedonly as temporary measures while a patient awaits a donor heart fortransplant.

Recently, improvements have been made in treating patient's with CHF byimplanting pacing leads in both sides of the heart in order tocoordinate the contraction of both ventricles of the heart. Thistechnique has been shown to improve hemodynamic performance and canresult in increased ejection fraction from the right ventricle to thepatient's lungs and the ejection fraction from the left ventricle to thepatient's aorta. While this procedure has been found to be successful inproviding some relief from CHF symtoms and slowed the progression of thedisease, it has not been able to stop the disease.

SUMMARY OF THE INVENTION

The present invention is directed to a ventricular partitioning deviceand method of employing the device in the treatment of a patient withcongestive heart failure (CHF). Specifically, the device partitions achamber of the patient's heart into a main productive portion and asecondary non-productive portion. This partitioning reduces the totalvolume of the heart chamber, reduces the stress applied to the heartand, as a result, improves the ejection fraction thereof.

A partitioning device embodying features of the invention has areinforced partitioning component with a concave, pressure receivingsurface which defines in part the main productive portion of thepartitioned heart chamber when secured within the patient's heartchamber.

The reinforced partitioning component preferably includes a hub and amembrane forming the pressure receiving surface. The partitioningcomponent is reinforced by a radially expandable frame component formedof a plurality of ribs.

The ribs of the expandable frame have distal ends secured to the centralhub and free proximal ends. The distal ends are preferably secured tothe central hub to facilitate radial self expansion of the free proximalends of the ribs away from a centerline axis. The distal ends of theribs may be pivotally mounted to the hub and biased outwardly or fixedto the hub and formed of material such as superelastic NiTi alloy whichallows for compressing the free proximal ends of the ribs toward acenterline axis into a contracted configuration and when released allowfor their self expansion to an expanded configuration.

The free proximal ends of the ribs are configured to engage andpreferably penetrate the tissue lining the heart chamber to bepartitioned so as to secure the peripheral edge of the partitioningcomponent to the heart wall and fix the partitioning component withinthe chamber so as to partition the chamber in a desired manner. Thetissue penetrating proximal tips are configured to penetrate the tissuelining at an angle approximately perpendicular to a center line axis ofthe partitioning device. The tissue penetrating proximal tips of theribs may be provided with barbs, hooks and the like which preventwithdrawal from the tips from the heart wall.

The ribs in their expanded configuration angle outwardly from the huband the free proximal ends curve outwardly so that the membrane securedto the ribs of the expanded frame forms a trumpet-shaped, pressurereceiving surface.

The partitioning membrane in the expanded configuration has radialdimensions from about 10 to about 160 mm, preferably about 50 to about100 mm, as measured from the center line axis.

The partitioning device may be delivered percutaneously orintraoperatively. One particularly suitable delivery catheter has anelongated shaft, a releasable securing device on the distal end of theshaft for holding the partitioning device on the distal end and anexpandable member such as an inflatable balloon on a distal portion ofthe shaft proximal to the distal end to press the interior of the recessformed by the pressure receiving surface to ensure that the tissuepenetrating tips or elements on the periphery of the partitioning devicepenetrate sufficiently into the heart wall to hold the partitioningdevice in a desired position to effectively partition the heart chamber.

The partitioning device embodying features of the invention isrelatively easy to install and it substantially improves the pumpingaction of the heart and provides an increase in the ejection fraction ofthe patient's heart chamber. These and other advantages of the inventionwill become more apparent from the following detailed description of theinvention and the accompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevational view of a partitioning device embodyingfeatures of the invention in an expanded configuration.

FIG. 2 is a plan view of the partitioning device shown in FIG. 1.

FIG. 3 is a partial longitudinal cross-sectional view of the hub of thepartitioning device shown in FIG. 1.

FIG. 4 is a transverse cross sectional view of the hub shown in FIG. 3taken along the lines 4-4.

FIG. 5 is a schematic elevational view of a delivery system for thepartitioning device shown in FIGS. 1 and 2.

FIG. 6 is a transverse cross-sectional view of the delivery system shownin FIG. 5 taken along the lines 6-6.

FIG. 7 is an elevational view, partially in section, of the hub shown inFIG. 3 secured to the helical coil of the delivery system shown in FIG.5.

FIGS. 8A-8E are schematic views of a patient's left ventricular chamberillustrating the deployment of the partitioning device shown in FIGS. 1and 2 with the delivery system shown in FIG. 5 to partition the heartchamber into a primary productive portion and a secondary,non-productive portion.

FIG. 9 is a partial schematic view of the expandable frame of thepartitioning device shown in FIGS. 1 and 2 in an unrestrictedconfiguration.

FIG. 10 is a top view of the expandable frame shown in FIG. 9.

FIGS. 11-13 are schematic illustrations of a method of forming thepartitioning device shown in FIGS. 1 and 2 from the expandable frameshown in FIGS. 9 and 10.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

FIGS. 1-4 illustrate a partitioning component 10 which embodies featuresof the invention and which includes a partitioning membrane 11, a hub12, preferably centrally located on the partitioning device, and aradially expandable reinforcing frame 13 formed of a plurality of ribs14. Preferably, the partitioning membrane 11 is secured to the proximalor pressure side of the frame 13 as shown in FIG. 1. The ribs 14 havedistal ends 15 which are secured to the hub 12 and free proximal ends 16which are configured to curve or flare away from a center line axis 17.Radial expansion of the free proximal ends 16 unfurls the membrane 11secured to the frame 13 so that the membrane presents a relativelysmooth, pressure receiving surface 18 which defines in part theproductive portion of the patient's partitioned heart chamber.

As shown in more detail in FIGS. 3 and 4, the distal ends 15 of the ribs14 are secured within the hub 12 and a transversely disposed connectorbar 20 is secured within the hub which is configured to secure the hub12 and thus the partitioning component 10 to a delivery system such asshown in FIG. 5 and 6. The curved free proximal ends 16 of ribs 14 areprovided with sharp tip elements 21 which are configured to hold theframe 13 and the membrane 11 secured thereto in a deployed positionwithin the patient's heart chamber. Preferably, the sharp tip elements21 of the frame 13 penetrate into tissue of the patient's heart wall inorder to secure the partitioning component 10 within the heart chamberso as to partition the ventricular chamber into a productive portion anda non-productive portion.

The connector bar 20 of the hub 12, as will be described later, allowsthe partitioning device 10 to be secured to a delivery system deliveryand to be released from the delivery system within the patient's heartchamber. The distal ends 15 of the reinforcing ribs 14 are securedwithin the hub 12 in a suitable manner or they may be secured to thesurface defining the inner lumen or they may be disposed within channelsor bores in the wall of the hub 12. The ribs 14 are preshaped so thatwhen not constrained other than by the membrane 11 secured thereto (asshown in FIGS. 1 and 2), the free proximal ends 16 thereof expand to adesired angular displacement away from a center line axis 17 which isabout 20° to about 90°, preferably about 50° to about 80°.

FIGS. 5-7 illustrate a suitable delivery system 30 delivering thepartitioning component 10 shown in FIGS. 1 and 2 into a patient's heartchamber and deploying the partitioning component 10 to partition theheart chamber as shown in FIGS. 8A-8E. The delivery system 30 includes aguide catheter 31 and a delivery catheter 32.

The guide catheter has an inner lumen 33 extending between the proximalend 34 and distal end 35. A hemostatic valve (not shown) may be providedat the proximal end 34 of the guide catheter 31. A flush port 36 on theproximal end 34 of guide catheter 31 is in fluid communication with theinner lumen 33.

The delivery catheter 32 has an outer shaft 40 with an inner lumen 41and a proximal injection port 42, an inner shaft 43 disposed within theinner lumen 41 with a first lumen 44 and a second lumen 45. Ballooninflation port 46 is in fluid communication with the first lumen 44 andflush port 47 is in fluid communication with the second lumen 45. Torqueshaft 48 is rotatably disposed within the second lumen 44 of the innershaft 43 and has an injection port 49 provided at its proximal end 50 influid communication with the inner lumen 51 of the torque shaft. Thetorque shaft 48 is preferably formed at least in part of a hypotubeformed of suitable material such as superelastic NITINOL or stainlesssteel. A torque knob 52 is secured to the proximal end 50 of torqueshaft 48 distal to the injection port 49. A helical coil screw 53 issecured to the distal end 54 of the torque shaft 48 and rotation of thetorque knob 52 on the proximal end 50 of the torque shaft 48 rotates thescrew 53 on the distal end 54 of torque shaft 48 to facilitatedeployment of a partitioning device 10. A inflatable balloon 55 issealingly secured to the distal end of the inner shaft 43 and has aninterior 56 in fluid communication with the first lumen 44. Inflationfluid may be delivered to the interior 56 through port 44 a in theportion of the inner shaft 43 extending through the balloon 55.Inflation of the balloon 55 by inflation fluid through port 57facilitates securing the partitioning component 10.

To deliver the partitioning component 10, it is secured to the distalend of the delivery catheter 32 by means of the helical coil screw 53.The partitioning component 10 is collapsed to a first, deliveryconfiguration which has small enough transverse dimensions to beslidably advanced through the inner lumen 33 of the guide catheter 31.Preferably, the guide catheter 31 has been previously percutaneouslyintroduced and advanced through the patient's vasculature, such as thefemoral artery, in a conventional manner to the desired heart chamber.The delivery catheter 32 with the partitioning component 10 attached isadvanced through the inner lumen 33 of the guide catheter 31 until thepartitioning component 10 is ready for deployment from the distal end ofthe guide catheter 31 into the patient's heart chamber 58 to bepartitioned.

The partitioning component 10 mounted on the screw 53 is urged partiallyout of the inner lumen 33 of the guide catheter 31 until the hub 12engages the heart wall as shown in FIG. 8B with the free proximal ends16 of the ribs 14 in a contracted configuration within the guidecatheter. The guiding catheter 31 is withdrawn while the deliverycatheter 32 is held in place until the proximal ends 16 of the ribs 14exit the distal end 35 of the guiding catheter. The free proximal ends16 of ribs 14 expand outwardly to press the sharp proximal tips 21 ofthe ribs 14 against and preferably into the tissue lining the heartchamber. This is shown in FIG. 8C.

With the partitioning component deployed within the heart chamber andpreferably partially secured therein, inflation fluid is introducedthrough the inflation port 46 into first lumen 44 of inner shaft 43 ofthe delivery catheter 32 where it is directed through port 44 a into theballoon interior 56 to inflate the balloon. The inflated balloon pressesagainst the pressure receiving surface 18 of the partitioning component10 to ensure that the sharp proximal tips 21 are pressed well into thetissue lining the heart chamber.

With the partitioning device 10 properly positioned within the heartchamber, the knob 52 on the torque shaft 48 is rotated counter-clockwiseto disengage the helical coil screw 53 of the delivery catheter 32 fromthe hub 12. The counter-clockwise rotation of the torque shaft 48rotates the helical coil screw 53 which rides on the connector bar 20secured within the hub 12. Once the helical coil screw 53 disengages theconnector bar 20, the delivery system 30, including the guide catheter31 and the delivery catheter 32, may then be removed from the patient.

The proximal end of the guide catheter 31 is provided with an flush port36 to inject therapeutic or diagnostic fluids through the inner lumen33. Similarly, the proximal end of the delivery catheter 32 is providedwith a flush port 42 in communication with inner lumen 41 foressentially the same purpose. An inflation port 46 is provided on theproximal portion of the delivery catheter for delivery of inflationfluid through the first inner lumen 44 to the interior 56 of the balloon55. Flush port 47 is provided in fluid communication with the secondinner lumen 45 of the inner shaft 43. An injection port 49 is providedon the proximal end of the torque shaft 48 in fluid communication withthe inner lumen 51 of the torque shaft for delivery of a variety offluids.

The partitioning component 10 partitions the patient's heart chamber 57into a main productive or operational portion 58 and a secondary,essentially non-productive portion 59. The operational portion 58 ismuch smaller than the original ventricular chamber 57 and provides foran improved ejection fraction. The partitioning increases the ejectionfraction and provides an improvement in blood flow. Over time, thenon-productive portion 59 fills first with thrombus and subsequentlywith cellular growth. Bio-resorbable fillers such as polylactic acid,polyglycolic acid, polycaprolactone and copolymers and blends may beemployed to initially fill the non-productive portion 59. Fillers may besuitably supplied in a suitable solvent such as DMSO. Other materialswhich accelerate tissue growth or thrombus may be deployed in thenon-productive portion 59.

FIGS. 9 and 10 illustrate the reinforcing frame 13 in an unstressedconfiguration and includes the ribs 14 and the hub 12. The ribs 14 havea length L of about 1 to about 8 cm, preferably, about 1.5 to about 4 cmfor most left ventricle deployments. The proximal ends 16 have a flaredconstruction. To assist in properly locating the device duringadvancement and placement thereof into a patient's heart chamber, parts,e.g. the distal extremity, of one or more of the ribs and/or the hub maybe provided with markers at desirable locations that provide enhancedvisualization by eye, by ultrasound, by X-ray, or other imaging orvisualization means. Radiopaque markers may be made with, for example,stainless steel, platinum, gold, iridium, tantalum, tungsten, silver,rhodium, nickel, bismuth, other radiopaque metals, alloys and oxides ofthese metals.

The partitioning device 10 is conveniently formed by placing athermoplastic tube 60, e.g. polyethylene, over the ribs 14 of the frame13 as shown in FIG. 11 until the proximal ends 16 of the ribs 14 extendout the ends of the thermoplastic tubes as shown in FIG. 12. A firstexpanded PTFE sheet 61 of appropriate size is placed in the femaleplaten 62 of the press 63. The frame 13 with tubes 60 slidably disposedover the ribs 14 is placed in platen 62 on top of the ePTFE sheet 61.The center portion of the sheet 61 may be provided with an openingthrough which the hub 12 extends. A second ePTFE sheet 64 is placed ontop of the ribs 14 of frame 13 as shown in FIG. 13. The male platen 65is heated, preferably to about 500° F., so that the thermoplastic tubes60 disposed over the ribs 14 fuse into the porous matrix of the ePTFEsheets 61 and 64. The fused thermoplastic material solidifies andsecures the sheets 61 and 64 to the ribs 14 and prevents theirdelamination during use.

While porous ePTFE material is preferred, the membrane 11 may be formedof suitable biocompatitble polymeric material which include Nylon, PET(polyethylene terephthalate) and polyesters such as Hytrel. The membrane11 is preferably foraminous in nature to facilitate tissue ingrowthafter deployment within the patient's heart. The delivery catheter 32and the guiding catheter 31 may be formed of suitable high strengthpolymeric material such as PEEK (polyetheretherketone), polycarbonate,PET, Nylon, and the like. Braided composite shafts may also be employed.

To the extent not otherwise described herein, the various components ofthe partitioning device and delivery system may be formed ofconventional materials and in a conventional manner as will beappreciated by those skilled in the art.

While particular forms of the invention have been illustrated anddescribed herein, it will be apparent that various modifications andimprovements can be made to the invention. Moreover, individual featuresof embodiments of the invention may be shown in some drawings and not inothers, but those skilled in the art will recognize that individualfeatures of one embodiment of the invention can be combined with any orall the features of another embodiment. Accordingly, it is not intendedthat the invention be limited to the specific embodiments illustrated.It is intended that this invention to be defined by the scope of theappended claims as broadly as the prior art will permit.

Terms such a “element”, “member”, “device”, “section”, “portion”,“step”, “means” and words of similar import, when used herein shall notbe construed as invoking the provisions of 35 U.S.C. §112(6) unless thefollowing claims expressly use the terms “means” followed by aparticular function without specific structure or “step” followed by aparticular function without specific action. Accordingly, it is notintended that the invention be limited, except as by the appendedclaims. All patents and patent applications referred to above are herebyincorporated by reference in their entirety.

1. A device for treating a patient with congestive heart failure bypartitioning a chamber of the patient's heart into a primary productiveportion and a secondary non-productive portion, comprising: a. apartitioning component which has an expandable frame formed of aplurality of ribs having distal ends secured to a central hub and freeoutwardly flared proximal ends and which has a proximal, pressurereceiving face forming a recess in an expanded, deployed configurationdefining in part the primary productive portion of the patient's heartchamber to be partitioned; and b. a plurality of tissue penetratingsecuring elements disposed at free ends of the ribs configured topenetrate tissue lining the heart chamber at an angle essentiallyperpendicular to the center line axis of the partitioning device tosecure the periphery of the partitioning device to the heart chamber. 2.The device of claim 1 wherein reinforced partitioning component has acontracted configuration for delivery to patient's heart chamber to bepartitioned.
 3. The device of claim 1 wherein the pressure receivingsurface of the partitioning component is formed at least in part of amembrane.
 4. The device of claim 3 wherein the membrane is foraminous.5. The device of claim 3 wherein the membrane is formed at least in partof a polymeric fabric.
 6. The device of claim 5 wherein the polymericfabric of the membrane is secured to the ribs by polymeric materialfused in the polymeric fabric.
 7. The device of claim 6 wherein thedistal ends of the ribs are configured to facilitate abduction of thefree proximal ends of the ribs away from a centerline axis to facilitateexpansion of the reinforced partitioning component.
 8. The device ofclaim 6 wherein the free proximal ends of the ribs are outwardly curved.9. The device of claim 8 wherein the free proximal ends of the ribs havetips which penetrate the tissue lining the heart chamber at an angle ofnot more than 30° away from a line perpendicular to the center line axisof the partitioning device.
 10. The device of claim 1 wherein thepressure receiving surface has radial dimensions from a center line axisof about 10 to about 160 mm.
 11. The device of claim 1 wherein thepressure receiving surface has radial dimensions from a center line axisof about 5 to about 80 mm.
 12. The device of claim 1 wherein the framehas about 3 to about 30 ribs.
 13. The device of claim 1 wherein theframe has about 6 to about 16 ribs.
 14. The device of claim 1 whereinthe expandable frame is self expanding.
 15. The device of claim 1wherein the frame is formed of superelastic NiTi, alloy which is in anaustenite phase when unstressed.
 16. The device of claim 1 wherein theframe is in a stress maintained martensite phase when delivered throughthe patient's vasculature to the patient's heart chamber.
 17. The deviceof claim 3 wherein the membrane is formed at least in part of expandedfluoropolymer.
 18. The device of claim 17 wherein the expandedfluoropolymer is polytetrafluoroethylene.
 19. A partitioning apparatusfor a patients heart chamber to Improve cardiac ejection fraction,comprising: a. a central hub component; b. an expandable frame componenthaving a plurality of ribs with free, outwardly flared proximal ends anddistal ends secured to the central hub component; c. a membranecomponent secured to the expandable frame ribs which defines a recessed,pressure receiving surface; and d. tissue penetrating tips on aplurality of free, outwardly flared proximal ends which are configuredto penetrate tissue lining the heart chamber to be partitioned at anangle essentially perpendicular to a center line axis of thepartitioning device.
 20. The partitioning apparatus of claim 30 whereinthe hub has a non-traumatic distal tip to engage the region of thepatients ventricular wall.
 21. The partitioning apparatus of claim 30wherein the non-traumatic distal tip has a bullet shape.
 22. Thepartitioning apparatus of claim 30 wherein the membrane component issecured to the proximal side of the ribs.
 23. The partitioning apparatusof claim 30 wherein the membrane component is secured to the distal sideof the ribs.
 24. An intracorporeal delivery catheter for a ventricularpartitioning device for treating a patient with CHF, comprising: a. anelongated shaft which has proximal and distal ends, a port proximal tothe distal end and an inner lumen In fluid communication with the port;b. a releasable securing element on the distal end of the elongatedshaft configured to secure and release a ventricular partitioningdevice; and c. an inflatable member on a distal portion of the elongatedshaft having an interior in fluid communication with the inner lumen inthe elongated shaft through the port therein which Is configured toexpand a reinforced membrane of the partitioning device.
 25. Theintracorporeal delivery catheter of claim 24 wherein the elongated shafthas an outer shaft member with an inner lumen and an inner shaft memberdisposed within the inner lumen of the outer shaft, which has proximaland distal end, which has a first inner lumen extending within the innershaft to the port proximal to the distal end of the inner shaft memberto provide inflation fluid to the interior of the inflatable member,which has a second port in the distal end thereof and a second innerlumen extending within the inner shaft to the port in the distal endthereof.
 26. The intracorporeal delivery catheter of claim 25 includinga torque shaft which has proximal and distal ends, which is rotatablydisposed within the second inner lumen of the inner shaft member andwhich has the releasable securing element on the distal end thereof forsecuring and releasing a ventricular partitioning device.
 27. Theintracorporeal delivery catheter of claim 26 wherein the releasablesecuring element on the distal end of the torque shaft is a helicalscrew connection element.
 28. The intracorporeal delivery catheter ofclaim 27 wherein the helical screw connection element on the distal endof the torque shaft is configured to engage a connector bar on thepartitioning device.
 29. An intracorporeal delivery catheter for aventricular partitioning device for treating a patient with CHF,comprising: a. an elongated outer shaft with an inner lumen; b. an innershaft which is disposed within the inner lumen of the outer shaft, whichhas a first inner lumen extending within the inner shaft to a portproximal to the distal end thereof, which has a second inner lumenextending within the inner shaft to the distal end thereof; a balloonmounted on a distal portion of the inner shaft having an interior influid communication with the first inner lumen through the port; c. atorque shaft which has proximal and distal ends, which is rotatablydisposed within the second inner lumen of the inner shaft, which has ascrew connection element on the distal end thereof extending out of thedistal end of the inner shaft and configured to receive a partitioningdevice; and d. an inflation port in fluid communication with the firstinner lumen of the inner shaft for delivery of inflation fluidtherethrough to the interior of the balloon.
 30. An Intracorporealpartitioning component comprising: a. a frame having a plurality of ribswith radially extending proximal ends and with distal ends secured to ahub; and b. at least one porous sheet material secured to the ribs ofthe frame by fused thermoplastic material within the porous sheetmaterial.
 31. The intracorporeal partitioning component of claim 30wherein at least one porous sheet is secured to the upper portion of theribs of the frame and at least one sheet is secured to the lower portionof the ribs of the frame by thermoplastic material within the poroussheets.
 32. A method of securing a porous polymeric sheet material torib components of a frame structure, comprising: a. sliding athermoplastic tube over one or more rib components of the frame; b.applying a porous sheet to the ribs covered with the thermoplasticpolymeric tubes to form an assembly; and c. heating the assembly to fusethe polymeric material of the thermoplastic tubes within the poroussheet.
 33. The method of claim 32 wherein a porous sheet is applied tothe upper surface of the frame.
 34. The method of claim 32 wherein aporous sheet is applied to the lower surface of the frame.
 35. Themethod of claim 32 wherein a first porous sheet is applied to the uppersurface of the frame and a second porous sheet is applied to the lowersurface of the frame.
 36. The method of claim 35 wherein the assembly isplaced onto a receiving platen of a press and a hot pressing platen ispressed against the assembly to fuse the thermoplastic polymericmaterial on the ribs of the frame within one or both of the porousmembranes.
 37. A method of treating a patient with congestive heartfailure by partitioning the patient's heart chamber, comprising: a.providing a reinforced membrane having a first contracted configurationfor delivery to the patient's heart chamber and a second expandedconfiguration for deployment within the patient's heart chamber; b.advancing the reinforced membrane in the first contracted configurationinto the chamber of the patient's heart; c. inflating an inflatablemember disposed within the membrane to expand the reinforced membrane tothe second expanded configuration to facilitate securing the reinforcedmembrane within the patient's heart chamber to partition the chamberinto a primary productive portion and a secondary non-productiveportion.
 38. The method of claim 37 wherein the reinforced membrane isadvanced into the patient's heart chamber through an inner lumen of adelivery catheter.
 39. The method of claim 38 wherein the inflatablemember is positioned on a distal portion of the delivery catheter. 40.The method of claim 37 wherein the expanding inflatable member secures aperipheral edge of the reinforced membrane to a wall defining at leastin part the patients heart chamber.
 41. The method of claim 37 wherein acentral portion of the expanded reinforced membrane is spaced from awall defining in part the patients heart chamber.
 42. The method ofclaim 38 wherein the reinforced membrane is positioned within an innerlumen of the delivery catheter in the first contracted configuration,and advanced therein to a discharge port in the distal end of thedelivery catheter and discharged from the discharge port into thepatient's heart chamber where the contracted reinforced membrane expandsto the second expanded configuration due at least in part to theexpanding inflatable member.
 43. The method of claim 38 wherein thedelivery catheter is percutaneously introduced into the patient'svasculature and advanced therein until the distal end of the deliverycatheter is disposed within the patients heart chamber.
 44. The methodof claim 40 wherein the edge of the reinforced membrane is secured to awall defining at least in part the heart chamber by anchoring elementsprovided on the edge of the reinforced membrane.
 45. The method of claim37 wherein the reinforced membrane is in part self expanding.
 46. Amethod of treating a patient with congestive heart failure, comprising:a. providing an expandable reinforced membrane having a periphery with aplurality of anchoring elements thereon; b. advancing the reinforcedmembrane in a contracted configuration within the patients vasculatureuntil the reinforced member is disposed within a chamber of thepatient's heart; and c. inflating a balloon within the contractedreinforced membranes to expand the reinforced membrane into an expandedconfiguration within the heart chamber to secure the periphery of thereinforced membrane to the heart wall by the anchoring elements on theperiphery of the reinforced membrane.
 47. A method of treating a patientwith congestive heart failure, comprising the steps of: a. providing anexpandable reinforced membrane having a periphery with a plurality ofanchoring elements thereon; b. advancing the reinforced membrane in acontracted configuration within the patient's vasculature until thereinforced member is disposed within a chamber of the patient's heart;and c. inflating a balloon within the contracted reinforced membranes toexpand the reinforced membrane into an expanded configuration within theheart chamber to secure the periphery of the reinforced membrane to theheart wall by the anchoring elements on the periphery of the reinforcedmembrane.
 48. An intracorporeal product comprising: a. a first componentconfigured for intracorporeal deployment; and b. at least one sheet ofePTFE material secured to the first component by fused thermoplasticmaterial therebetween.
 49. The intracorporeal product of claim 30wherein a second ePTFE sheet is secured to the first component bythermoplastic material within the porous sheets.
 50. A method of makingan intracorporeal product securing a porous polymeric sheet material torib components of a frame structure, comprising: a. providing a ePTFEsheet; b. providing an intracorporeal component; c. deploying athermoplastic element over at least part of the intracorporealcomponent; d. applying the ePTFE sheet to at least a portion of theintracorporeal component covered by the at least one thermoplasticelement to form an assembly; and e. heating the assembly to fuse thethermoplastic material and secure the ePTFE sheet to the intracorporealcomponent.
 51. The method of claim 50 wherein the ePTFE sheet is appliedto an upper surface of the intracorporeal component.
 52. The method ofclaim 50 wherein the ePTFE sheet is applied to a lower surface of theintracorporeal component.
 53. The method of claim 51 wherein a secondePTFE sheet is applied to the lower surface of the intrecorporealcomponent.
 54. The method of claim 50 wherein pressure is applied to theassembly at elevated temperature to fuse the thermoplastic polymericmaterial and secure the ePTFE sheet to the intracorporeal component.